Clinical trials: Ribociclib
HER2 Negative Breast Cancer Not Immediately Operated
Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS)
Women aged 70 years or older, newly diagnosed for locally advanced unilateral breast cancer, with a histological diagnosis of invasive mammary carcinoma, positive hormone receptors, HER2 status Negative, not immediately operable…
- Trial name
- CALHYS (NCT05664893)
- Testing
- Ribociclib Oral Tablet
- Where
- France
- Sponsor
- Centre Antoine Lacassagne
Breast Neoplasm, Metastatic Breast Cancer
[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer
In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer [18F]fluorothymidine (FLT).
- Conditions
- Breast Neoplasm, Metastatic Breast Cancer, Rb+ Breast Cancer
- Trial name
- NCT02608216
- Testing
- [18F]FLT, PET/CT, ribociclib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Pennsylvania
Any Solid Oral Medication
Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
Primary Objective: To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation.
- Trial name
- NCT06344416
- Testing
- Use of ReX to dispense and monitor solid oral medication therapy.
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Dosentrx Ltd.
Malignant Rhabdoid Tumors (MRT), Neuroblastoma
Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma
LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended…
- Trial name
- NCT01747876
- Testing
- LEE011
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Advanced or Metastatic ER+ Breast Cancer
Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with…
- Trial name
- NCT02734615
- Testing
- LSZ102, LEE011, BYL719
- Where
- 10 sites in United States, Belgium and 5 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer
Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in women or men aged 70 years-old or older, with hormone receptor positive/HER2…
- Trial name
- FACILE (NCT03944434)
- Testing
- Ribociclib, Aromatase Inhibitors, non steroideal, LHRH agonist
- Where
- Italy
- Volunteers
- 116 people
- Sponsor
- Fondazione Sandro Pitigliani
Breast Cancer
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
The purpose of this trial is to estimate the recommended dose (RD) of [177Lu]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor…
- Trial name
- NCT05870579
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Ribociclib
- Where
- 13 sites in United States, China and 5 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Glioblastoma Multiforme, Glioma of Brain
A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection
In the proposed trial, patients will be administered ribociclib+everolimus prior to surgical resection of their tumor. Recurrent GBM patients will be randomized into one of the three time-interval cohorts for the first two dose…
- Trial name
- NCT03834740
- Testing
- Ribociclib, Everolimus
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
Ovarian Cancer, Fallopian Tube Cancer
Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer
Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance the response to platinum-based therapy and maintenance therapy will slow ovarian cancer tumor growth leading to prolongation in…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- Trial name
- NCT03056833
- Testing
- ribociclib, Paclitaxel, Carboplatin
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- Ronald Buckanovich
Metastatic Breast Cancer
A Study of Real-world Outcomes Among Patients Treated With Ribociclib
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative…
- Trial name
- NCT07148505
- Where
- United States
- Volunteers
- 373 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer
The RibOB study is a prospective, open lable, single arm trial which will evaluate the clinical efficacy, overall safety and tolerability of ribociclib in combination with letrozole in older women (≥70 years) with HR+/HER2- aBC…
- Trial name
- RibOB (NCT03956654)
- Testing
- Ribociclib
- Where
- Belgium
- Volunteers
- 78 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Advanced or Metastatic Breast Cancer
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
This is a multi-center, open-label, non-randomized, phase I study
- Trial name
- LeeBLet (NCT02154776)
- Testing
- LEE011, Buparlisib, Letrozole
- Where
- 6 sites in United States, Spain
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
EGFR-mutant Non-small Cell Lung Cancer
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced Epidermal growth factor…
- Trial name
- NCT03333343
- Testing
- EGF816, trametinib, ribociclib
- Where
- 11 sites in Canada, Germany and 4 more
- Volunteers
- 105 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor, Lymphomas
A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.
LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6. CDK4/6 is involved in the process that allows both normal and cancer cells to divide and multiply.
- Trial name
- NCT01237236
- Testing
- LEE011
- Where
- 7 sites in United States, France and 1 more
- Volunteers
- 156 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
ER+ Breast Cancer, Breast Cancer
Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence.
Hormone receptor-positive (HR+) breast cancers represent the most common histological subtype of breast cancer, accounting for approximately 75% of cases, regardless of HER2 (human epidermal growth factor receptor 2) status (1).
- Conditions
- ER+ Breast Cancer, Breast Cancer, Early Breast Cancer, Endocrine Therapy
- Trial name
- AdheRA (NCT07443774)
- Where
- France
- Volunteers
- 81 people
- Sponsor
- University Hospital, Grenoble
Breast Cancer
Real-world Studies of CDK4/6 Inhibitors
A single-center, real-world study evaluated the clinical outcomes and safety of CDK4/6 inhibitors combined with endocrine therapy in HR+/HER2- advanced breast cancer, and conducted a summary analysis of the clinical treatment…
- Trial name
- NCT07407439
- Where
- China
- Volunteers
- 245 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients…
- Trial name
- NCT02333370
- Testing
- LEE011, Letrozole, Tamoxifen
- Where
- 15 sites in Hong Kong, Japan and 1 more
- Volunteers
- 88 people
- Sponsor
- Novartis Pharmaceuticals
Liposarcoma
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma
To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.
- Trial name
- NCT02343172
- Testing
- HDM201, LEE011
- Where
- 9 sites in Canada, France and 4 more
- Volunteers
- 74 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase I Evaluating the Combination of Ribociclib+Capecitabine in Locally Advanced/Metastatic Breast Cancer HER2 Negative
The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced or metastatic breast cancer HER2 negative patients and divided into 2 parts: STEP 1: a dose escalation part (n= up to 30) to evaluate…
- Trial name
- GEP14-LEECAP (NCT02754011)
- Testing
- Combination of ribociclib + capecitabine
- Where
- 2 sites in France
- Volunteers
- 18 people
- Sponsor
- UNICANCER